1. The Field of the Invention
The present invention relates to methods and systems for forming fluid connections including sterile fluid connections.
2. The Relevant Technology
The biotechnology and pharmaceutical industries are increasingly moving towards the use of disposable polymeric containers and tubing in their manufacturing and processing of sterile liquid product. For example, newly developed bioreactors, which are used in growing cells or microorganisms, commonly comprise a large polymeric bag-like container that is positioned within a rigid support vessel. The cells or microorganisms are grown within the polymeric bag while polymeric tubing coupled with the container is used for adding and removing material from the container. Once a batch is completed, the polymeric bag and tubing are disposed of and a new bag with tubing is used for the next batch. The use of disposable containers and tubing eliminates or at least minimizes the need for cleaning and sterilizing equipment between batches and helps improve quality control.
Although the use of disposable container systems has simplified production and processing, there are still a number of shortcomings with such systems that need to be addressed. One significant issue is how to make sterile connections for moving fluids. That is, although container systems with associated tubing can be sealed and sterilized prior to use, such as through radiation, sterile fluid connections need to be made in the field to enable movement of materials into and out of the container. Typically, such connections are made through an aseptic connection method (i.e., quick disconnect under a laminar hood or use of KLEENPAK connectors produced by Pall Corporation), steam-in-place connection method, filter connection, or a tube weld connection method. Currently, both aseptic and sterile systems available require specifically designed components and processes/methods to ensure the efficacy of the connection.
Connector systems have been made for forming sterile fluid connections on small diameter tubing used with blood bags outside of a sterile environment. Examples of such connectors are disclosed in U.S. Pat. Nos. 4,157,723; 4,265,280; and 4,325,417. Such connector systems comprise a pair of small diameter connectors each having an opaque membrane that seals the opening to the connectors closed. To facilitate a sterile fluid connection, the connectors are coupled together with the membranes adjacently disposed. A radiant energy or other form of energy is then applied to the connectors which melts the membranes so as to enable fluid communication between the connectors.
Although the above connectors are useful for their intended use with small diameter tubes on blood bags, the connectors are not scalable. That is, such connectors are not designed to be scaled for use with large diameter tubing that is traditionally used by the biotechnology and pharmaceutical industries in large scale manufacturing and processing. Furthermore, such connectors typically require the fluid to pass through single or multiple sharp right angles as the fluid passes through the coupled connectors. Where cells or microorganisms are being transported, such connectors create undesirable shear forces that can damage the cells or microorganisms.
Accordingly, what is needed in the art are connection systems for forming sterile fluid connections outside of a sterile environment and which can be used with large diameter tubing for the large scale flow of sterile fluids.